Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 10:43 PM
Study NCT ID:
NCT05578651
Status:
WITHDRAWN
Last Update Posted:
2025-01-16
First Post:
2022-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Zimmer Biomet has no current plans to market this product in EMEA.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of sternal wound infection', 'timeFrame': '30 days', 'description': 'Rate of deep sternal wound infection and superficial sternal wound infection'}], 'secondaryOutcomes': [{'measure': 'Quality of recovery after surgery', 'timeFrame': '60 days', 'description': 'QoR-15 instrument'}, {'measure': 'Days alive and out of the hospital', 'timeFrame': '60 days', 'description': 'Calculation of time'}, {'measure': 'Disability-free survival', 'timeFrame': '60 days', 'description': 'WHODAS 2.0 instrument'}, {'measure': 'Pain score', 'timeFrame': '60 days', 'description': 'Numerical Rating Pain Score'}, {'measure': 'Opioid medication usage', 'timeFrame': '60 days', 'description': 'Milligrams of morphine equivalency administered'}, {'measure': 'Inspirometry vital capacity', 'timeFrame': '60 days', 'description': 'Milliliters of spirometry capacity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Rigid Plate Fixation', 'Median Sternotomy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.', 'detailedDescription': 'The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary.\n\nThe primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \\& SSWI) at 30 days post-op.\n\nThe secondary endpoints of evaluation up to 60-days post-operative are defined by:\n\n* Quality of recovery after surgery (QoR-15)\n* Days alive out of the hospital and at home (DAH)\n* Disability-free survival (WHODAS 2.0.)\n* Pain scores: Likert scale 1-10\n* Opioid pain medication usage\n* Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Received median sternotomy with rigid plate fixation after a cardiac procedure (e.g., valve replacement or repair, bypass grafting)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female\n* ≥ 18 years of age, no upper limit\n* Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \\[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\\] and closed with the SternaLock XP Rigid Fixation System\n* Willing to sign Informed Consent prior to the cardiac surgical procedure\n* Willing and able to provide follow-up information up to 60-days post-operative\n\nExclusion Criteria:\n\nInclusion Criteria\n\n* Male and female\n* ≥ 18 years of age, no upper limit\n* Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \\[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\\] and closed with the SternaLock XP Rigid Fixation System\n* Willing to sign Informed Consent prior to the cardiac surgical procedure\n* Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria\n\nPre-operative\n\n* Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia\n* Active or latent infection (with positive culture)\n* Documented foreign body sensitivity, allergy, or intolerance to metals.\n* Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.\n* Mental/ neurologic conditions rendering patients unwilling or incapable of following post-operative care instructions.\n* Functional disability affecting gait, balance or mobility.\n\nOperative\n\n* Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)\n* Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.\n* Insufficient quantity of sternal bone or limited blood supply as assessed by the operating surgeon using his or her professional judgment at the time of closure.\n* Intraoperative death prior to device placement'}, 'identificationModule': {'nctId': 'NCT05578651', 'acronym': 'RACE XP', 'briefTitle': 'A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP', 'orgStudyIdInfo': {'id': '0821-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SternaLock XP', 'description': 'Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method', 'interventionNames': ['Device: SternaLock XP']}], 'interventions': [{'name': 'SternaLock XP', 'type': 'DEVICE', 'description': 'Plating system with cable cerclage bands that is used in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy', 'armGroupLabels': ['SternaLock XP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03102', 'city': 'Manchester', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Catholic Medical Center', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}